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Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, appear banking after-effects for the fourth division and year assured December 31, 2019. Unless contrarily stated, all comparisons are for the fourth division and abounding year 2019, compared to the fourth division and abounding year 2018.

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Product revenue, net consists absolutely of sales acquirement from NERLYNX®, Puma’s aboriginal bartering product. Net artefact acquirement in the fourth division of 2019 was $58.7 million, compared to net artefact acquirement of $61.1 actor in the fourth division of 2018. Net artefact acquirement for the abounding year 2019 was $211.6 million, compared to net artefact acquirement of $200.5 actor for the abounding year 2018.

Based on accounting attempt about accustomed in the United States (GAAP), Puma appear a net accident of $11.2 million, or $0.29 per share, for the fourth division of 2019, compared to a net accident of $30.7 million, or $0.80 per share, for the fourth division of 2018. Net accident for the abounding year 2019 was $75.6 million, or $1.95 per share, compared to $113.6 million, or $2.99 per share, for the abounding year 2018.

Non-GAAP adapted net assets was $0.3 million, or $0.01 per share, for the fourth division of 2019, compared to non-GAAP adapted net accident of $12.2 million, or $0.32 per share, for the fourth division of 2018. Non-GAAP adapted net accident for the abounding year 2019 was $18.3 million, or $0.47 per share, compared to non-GAAP adapted net accident of $26.7 million, or $0.70 per share, for the abounding year 2018. Non-GAAP adapted net assets (loss) excludes stock-based advantage expense. For a adaptation of GAAP net accident to non-GAAP adapted net assets (loss) and GAAP net accident per allotment to non-GAAP adapted net assets (loss) per share, amuse see the banking tables at the end of this account release.

Net banknote provided by operating activities for the fourth division of 2019 was $1.6 million, compared to net banknote provided by operating activities of $7.1 actor for the fourth division of 2018. Net banknote provided by operating activities for the abounding year 2019 was $22.4 million, compared to net banknote acclimated in operating activities of $24.1 actor for the abounding year 2018. At December 31, 2019, Puma had cash, banknote equivalents and bankable balance of $111.6 million, compared to $165.4 actor at December 31, 2018.

“During 2019, Puma fabricated ample strides to admission all-around bartering admission to NERLYNX by HER2-positive breast blight patients, as able-bodied as to aggrandize the characterization and abeyant ameliorative break of NERLYNX,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “Our year assured with a characterization amplification to abode NERLYNX ancillary effects, allotment approval in Hong Kong and business approval in Singapore for NERLYNX, an broadcast allotment acceding with Pierre Fabre, as able-bodied as several analytic abstracts presentations at SABCS. We accept these regulatory, commercial, partnering and analytic milestones position Puma for bigger after-effects in 2020 and beyond.”

Mr. Auerbach added, “We ahead the afterward key milestones over the abutting 12 months: (i) modifying the SUMMIT bassinet balloon to aggrandize the HER2-mutated breast blight accomplice in the aboriginal division of 2020; (ii) accepting a [U.S.] authoritative accommodation on neratinib in third-line HER2-positive metastatic breast blight in the added division of 2020; (iii) administering a pre-NDA affair with the FDA to altercate accelerated approval of neratinib in HER2 mutated hormone receptor absolute breast blight and HER2 mutated cervical blight in the fourth division of 2020; (iv) advertisement Phase II abstracts from the HER-positive breast and cervical blight cohorts from the SUMMIT balloon of neratinib in patients with HER2 mutations in the fourth division of 2020; (v) advertisement added abstracts from the Phase II CONTROL balloon in the fourth division of 2020; and (vi) accepting authoritative decisions for an connected accessory HER2-positive aboriginal date breast blight adumbration in added countries.”

Revenue

Total acquirement consists of artefact revenue, net from sales of NERLYNX, Puma’s aboriginal bartering product, allotment acquirement and ability revenue. For the fourth division of 2019, absolute acquirement was $62.9 million, of which $58.7 actor was net artefact revenue, $4.0 actor was allotment acquirement accustomed from Puma’s sub-licensees, and $0.2 actor was ability revenue. This compares to absolute acquirement of $71.1 actor in the fourth division of 2018, of which $61.1 actor was net artefact acquirement and $10.0 actor was allotment acquirement accustomed from Puma’s sub-licensees. For the year assured December 31, 2019, absolute acquirement was $272.3 million, of which $211.6 actor was net artefact revenue, $60.3 actor was allotment acquirement accustomed from Puma’s sub-licensees and $0.4 actor was ability revenue. This compares to absolute acquirement of $251.0 actor for the year assured December 31, 2018, of which $200.5 actor was net artefact acquirement and $50.5 actor was allotment acquirement accustomed from Puma’s sub-licensees.

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Operating Costs and Expenses

Total operating costs and costs were $71.6 actor for the fourth division of 2019, compared to $89.7 actor for the fourth division of 2018. Absolute operating costs and costs were $311.4 actor for the abounding year 2019 compared to $345.7 actor for the abounding year 2018.

Cost of Sales

Cost of sales was $10.1 actor for the fourth division of 2019 and $36.8 actor for the abounding year 2019, compared to $10.3 actor for the fourth division of 2018 and $34.6 actor for the abounding year 2018.

Selling, Accepted and Authoritative Expenses

Selling, accepted and authoritative costs were $31.3 actor for the fourth division of 2019, compared to $41.0 actor for the fourth division of 2018. Selling, accepted and authoritative costs for the abounding year 2019 were $141.7 million, compared to $146.2 actor for abounding year 2018, a abatement of about $4.5 million. The abatement in SG&A costs for the abounding year 2019 primarily accompanying to decreases in stock-based advantage amount of about $7.0 million, and amount and accompanying costs of about $1.3 million. These decreases were partially account by an admission in able fees and costs of about $2.7 actor and an crime accident of about $1.2 million.

Research and Development Expenses

Research and development costs were $30.2 actor for the fourth division of 2019, compared to $38.4 actor for the fourth division of 2018. Analysis and development costs for the abounding year 2019 were $132.9 million, compared to $164.9 actor for the abounding year 2018. The abatement of about $32.0 actor for the abounding year 2019 resulted primarily from decreases in stock-based advantage amount of about $22.6 million, centralized R&D amount of about $4.7 million, analytic balloon costs of about $4.2 million, and adviser and architect costs of about $0.5 million.

Total Added Assets (Expenses)

Total added costs were $2.5 actor for the fourth division of 2019, compared to $12.1 actor for the fourth division of 2018. Absolute added costs were $36.5 actor for the year assured December 31, 2019, compared to $18.9 actor for the year assured December 31, 2018. The admission of $17.6 actor during the abounding year 2019 compared to the abounding year 2018 primarily resulted from an admission in debt concealment accident of about $8.1 million, an admission in acknowledged adjudication amount of about $7.4 million, and an admission in absorption amount of about $4.0 million, partially account by an admission in absorption and added assets of about $1.9 million.

Conference Call

Puma Biotechnology will host a appointment alarm to address its fourth division and abounding year 2019 banking after-effects and accommodate an amend on the Company’s business and angle at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 20, 2020. The alarm may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Amuse punch in at atomic 10 account in beforehand and acquaint the abettor that you would like to accompany the “Puma Biotechnology Appointment Call.” A alive webcast of the appointment alarm and presentation slides may be accessed on the Investors area of the Puma Biotechnology website at http://www.pumabiotechnology.com. A epitomize of the alarm will be accessible about one hour afterwards achievement of the alarm and will be archived on Puma’s website for 90 days.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical aggregation with a focus on the development and commercialization of avant-garde articles to enhance blight care. Puma in-licenses the all-around development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, articulate was accustomed by the U.S. Aliment and Drug Administration in 2017 for the connected accessory analysis of developed patients with aboriginal date HER2-overexpressed/amplified breast cancer, afterward accessory trastuzumab-based analysis and is marketed in the United States as NERLYNX® (neratinib) tablets. NERLYNX was accepted business allotment by the European Commission in 2018 for the connected accessory analysis of developed patients with aboriginal date hormone receptor-positive HER2-overexpressed/amplified breast blight and who are beneath than one year from achievement of above-mentioned accessory trastuzumab-based therapy. NERLYNX is a registered brand of Puma Biotechnology, Inc.

Further advice about Puma Biotechnology may be begin at www.pumabiotechnology.com.

Important Assurance Advice Apropos NERLYNX® (neratinib) U.S. Indication

NERLYNX® (neratinib) tablets, for articulate use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor adumbrated for the connected accessory analysis of developed patients with HER2 overexpressed/amplified breast cancer, to chase accessory trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The best accepted adverse reactions (≥ 5%) were diarrhea, nausea, belly pain, fatigue, vomiting, rash, stomatitis, decreased appetite, beef spasms, dyspepsia, AST or ALT increase, attach disorder, dry skin, belly distention, weight decreased and urinary amplitude infection.

To address SUSPECTED ADVERSE REACTIONS, acquaintance Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Please see Abounding Prescribing Advice for added assurance information.

The recommended dosage of NERLYNX is 240 mg (six 40 mg tablets) accustomed orally already circadian with food, continuously for one year. Antidiarrheal prophylaxis should be accomplished with the aboriginal dosage of NERLYNX and connected during the aboriginal 2 months (56 days) of analysis and as bare thereafter.

To advice ensure patients accept admission to NERLYNX, Puma has implemented the Puma Patient Lynx abutment affairs to abetment patients and healthcare providers with agreement abutment and referrals to assets that can advice with banking assistance. Added advice on the Puma Patient Lynx affairs can be begin at www.NERLYNX.com or 1-855-816-5421.

Forward-Looking Statements

This account absolution includes advanced statements, including statements apropos Puma’s advancing milestones. All advanced statements absorb risks and uncertainties that could account absolute after-effects to alter materially from the advancing after-effects and expectations bidding in these advanced statements. These statements are based on accepted expectations, forecasts and assumptions, and absolute outcomes and after-effects could alter materially from these statements due to a cardinal of factors, which include, but are not bound to, the accident factors appear in the alternate and accepted letters filed by Puma with the Balance and Exchange Commission from time to time, including, already filed, Puma’s Annual Address on Form 10-K for the year assured December 31, 2019. Readers are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date hereof. Puma assumes no obligation to amend these advanced statements, except as appropriate by law.

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2019

2018

2019

2018

(Unaudited)

(Unaudited)

(Unaudited)

$

58.7

$

61.1

$

211.6

$

200.5

4.0

10.0

60.3

50.5

0.2

0.4

62.9

71.1

272.3

251.0

10.1

10.3

36.8

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34.6

31.3

41.0

141.7

146.2

30.2

38.4

132.9

164.9

71.6

89.7

311.4

345.7

(8.7

)

(18.6

)

(39.1

)

(94.7

)

0.5

0.7

2.8

1.8

(3.1

)

(3.8

)

(15.0

)

(11.0

)

(9.0

)

(16.4

)

(9.0

)

(8.1

)

0.1

0.2

(0.7

)

(2.5

)

(12.1

)

(36.5

)

(18.9

)

$

(11.2

)

$

(30.7

)

$

(75.6

)

$

(113.6

)

$

(0.29

)

$

(0.80

)

$

(1.95

)

$

(2.99

)

39,043,706

38,201,056

38,768,653

37,942,411

December 31,

December 31,

2019

2018

(Unaudited)

$

60.0

$

108.4

51.6

57.0

66.6

135.9

17.5

34.3

Twelve Months

Twelve Months

Ended

Ended

December 31,

December 31,

2019

2018

(Unaudited)

$

22.4

$

(24.1

)

5.2

(57.6

)

(67.1

)

108.4

$

(39.5

)

$

26.7

Non-GAAP Banking Measures

In accession to operating after-effects as affected in accordance with GAAP, Puma uses assertive non-GAAP banking measures back planning, monitoring, and evaluating operational performance. The afterward table presents the Company’s net accident and net accident per allotment affected in accordance with GAAP and as adapted to abolish the appulse of agent stock-based compensation. For the three months and twelve months assured December 31, 2019 stock-based advantage represented about 18.7% and 20.9% of operating expenses, respectively, in anniversary case excluding amount of sales. Puma’s administration believes that these non-GAAP banking measures are advantageous to enhance compassionate of Puma’s banking performance, and are added apocalyptic of its operational achievement and facilitate a bigger allegory amid budgetary periods. These non-GAAP banking measures are not, and should not be beheld as, substitutes for GAAP advertisement measures.

Three Months Assured December 31,

2019

2018

$

(11.2

)

$

(30.7

)

5.0

7.9

(1)

6.5

10.6

(2)

$

0.3

$

(12.2

)

$

(0.29

)

$

(0.80

)

0.30

0.48

$

0.01

$

(0.32

)

(3)

$

(0.29

)

$

(0.80

)

0.30

0.48

$

0.01

(4)

$

(0.32

)

(5)

Twelve Months Assured December 31,

2019

2018

$

(75.6

)

$

(113.6

)

27.9

34.9

(1)

29.4

52.0

(2)

$

(18.3

)

$

(26.7

)

$

(1.95

)

$

(2.99

)

1.48

2.29

$

(0.47

)

$

(0.70

)

(6)

 

View antecedent adaptation on businesswire.com: https://www.businesswire.com/news/home/20200220005300/en/

Contacts

Alan H. Auerbach or Mariann OhanesianPuma Biotechnology, Inc. 1 424 248 [email protected] [email protected]

David Schull or Maggie BellerRusso Partners 1 212 845 [email protected] [email protected]

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